Device Classification Name |
device, vascular, for promoting embolization
|
510(k) Number |
K220699 |
Device Name |
Prestige Coil System |
Applicant |
Bait USA, LLC |
29 Parker |
Irvine,
CA
92618
|
|
Applicant Contact |
Michael Peters |
Correspondent |
Bait USA, LLC |
29 Parker |
Irvine,
CA
92618
|
|
Correspondent Contact |
Michael Peters |
Regulation Number | 870.3300
|
Classification Product Code |
|
Date Received | 03/10/2022 |
Decision Date | 04/08/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|